Hospira™ Bortezomib

Land: New Zealand

Sprog: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv bestanddel:

Bortezomib 3mg (as a mannitol boronic ester)

Tilgængelig fra:

Pfizer New Zealand Limited

Dosering:

3 mg

Lægemiddelform:

Powder for injection

Sammensætning:

Active: Bortezomib 3mg (as a mannitol boronic ester) Excipient: Mannitol

Recept type:

Prescription

Terapeutiske indikationer:

Bortezomib in combination with melphalan and prednisone, is indicated for the treatment of patients with previously untreated multiple myeloma, who are not suitable for high dose chemotherapy. Bortezomib as part of combination therapy, is indicated for induction therapy prior to high dose chemotherapy with autologous stem cell rescue for patients under 65 years of age with previously untreated multiple myeloma. Bortezomib is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease.

Produkt oversigt:

Package - Contents - Shelf Life: Vial, glass, Clear type I with rubber stopper and aluminium seal in cardboard carton - 1 dose units - 36 months from date of manufacture stored at or below 25°C 8 hours reconstituted stored at or below 25°C

Autorisation dato:

2018-01-08

Produktets egenskaber

Version: pfdborhv10323
Supersedes: pfdborhv11221
Page 1 of 40
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Hospira™ Bortezomib 1 mg, 2.5 mg, 3.0 mg, 3.5 mg powder for
injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each single dose vial contains:
•
1mg of bortezomib as a sterile lyophilised powder
•
2.5 mg of bortezomib as a sterile lyophilised powder
•
3.0 mg of bortezomib as a sterile lyophilised powder
•
3.5 mg of bortezomib as a sterile lyophilised powder
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for Injection.
Hospira Bortezomib Powder for Injection is supplied as white, to off
white lyophilised powder.
The solubility of bortezomib, as the monomeric boronic acid, in water
is: 3.3 – 3.8 mg/mL in
a pH range of 2 – 6.5.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS_ _
Hospira Bortezomib powder for injection in combination with melphalan
and prednisone, is
indicated for the treatment of patients with previously untreated
multiple myeloma, who are
not suitable for high dose chemotherapy.
Hospira Bortezomib powder for injection, as part of combination
therapy, is indicated for
induction therapy prior to high dose chemotherapy with autologous stem
cell rescue for patients
under 65 years of age with previously untreated multiple myeloma
Hospira Bortezomib powder for injection is also indicated for the
treatment of multiple
myeloma patients who have received at least one prior therapy, and who
have progressive
disease.
4.2 DOSE AND METHOD OF ADMINISTRATION
RECOMMENDED DOSAGE
HOSPIRA
BORTEZOMIB
POWDER
FOR
INJECTION
IS
FOR
INTRAVENOUS
OR
SUBCUTANEOUS USE ONLY. INTRATHECAL ADMINISTRATION HAS RESULTED IN
DEATH.
Hospira Bortezomib Powder for Injection may be administered:
•
Intravenously (at a concentration of 1 mg/mL) as a 3-5 second bolus
injection or
Version: pfdborhv10323
Supersedes: pfdborhv11221
Page 2 of 40
•
Subcutaneously (at a concentration of 2.5 mg/mL).
Because each route of administration has a different reconstituted
concentration, caution should